A medical director contacted me recently to ask for help with DEA compliance at a 24/7 emergency hospital. While I discussed the options, the veterinarian asked, “Wouldn’t it be more productive to give me a list of problems and solutions?” If only it were that easy! I explained that the Controlled Substances Act and Title 21 of the Code of Federal Regulations set forth federal laws regarding controlled substances and that the issues veterinary professionals might experience are impossible to quantify into a list.
Like with a patient’s health, compliance with the U.S. Drug Enforcement Administration can span a multitude of concerns and needs, with varying degrees of severity that are facility or operationally specific.
A common ailment among veterinary professionals is DEA noncompliance. I regularly hear:
- “The regulations are too confusing.”
- “I don’t have time.”
- “None of this was taught in vet school.”
- “Nobody else has been caught in my area.”
- “What, me worry?”
While those points might be valid, the reality is that neglecting DEA compliance can lead to serious and sometimes devastating consequences. Curing noncompliance is not a one-and-done task. It requires a solid plan and ongoing maintenance. In many ways, it’s like patient health care.
Remember the exhortations during the pandemic to wash your hands thoroughly with soap to avoid getting and spreading COVID-19? In veterinary terms, SOAP notes are a structured record of a patient encounter, with the acronym standing for subjective, objective, assessment and plan. SOAP also may be used to identify and correct DEA compliance issues.
Your Patient
Think of DEA compliance, and specifically a DEA registration, as your patient. As a veterinary professional, you know that neglecting patient care can lead to undiagnosed or worsening conditions, even death. DEA compliance is no different. If you have a registration and don’t do what is required to maintain the privilege, you set yourself up for negative professional and personal repercussions.
Many veterinary professionals have told me they don’t know how to start working on DEA compliance. My recommendation is to do it the same way they would with a patient: by gathering information.
If you follow the SOAP method for patient documentation and treatment plans, you start by gathering information. The same is true in DEA compliance. What are the identifiable issues? Are any of them new or recurring? Have any notable changes occurred to operations, records or the drug inventory?
You also need to think about:
- Which team members do I trust to work with controlled substances?
- What products do I now have in inventory, and which ones will I have in the future?
- Do I have the correct logs, and do I know how to complete them?
- Which standard operating procedures are in place to order controlled substances, inventory them, and dispose of and destroy them?
Subjective
Signs and symptoms are part of the subjective information-gathering process. Symptoms of DEA noncompliance indicate an issue you must address immediately. Noncompliance can present in many forms. For example:
- Discrepancies between logbooks and inventory counts could be a symptom of mathematical errors and poor logging habits. Or they could be a sign of drug diversion.
- Containers of liquid controlled substances with excess fluid could be a symptom of manufacturer overfill. Or someone might be diverting the drug and replacing it with saline.
- Missing DEA Form 222s may indicate a lack of understanding that an original copy must be created and retained before submission to a supplier. Or it could be a warning of internal theft.
Treating symptoms when they arise is essential, but focusing solely on them is unlikely to cure DEA noncompliance. Treating the symptoms alone is ineffective because they might mask other issues.
Objective
Once you gather subjective information, the next step is an objective examination — the “O” in SOAP.
If you are unsure of your DEA compliance status, you must review the data, including required records such as logbooks, invoices, Form 222s and destruction documents. As you proceed, ask yourself, “Are patient log entries complete and balanced out?” and “Are all invoices and DEA Form 222s accounted for?”
Compliance records should tell the complete story of your controlled substances from the time of purchase, through usage, to when each container is depleted or expired and subsequently sent for final destruction. You have a good indicator of compliance when your records tell the whole story on their own. If they do not, you need to get to work by assessing your controlled substances compliance program.
Assessment
Now we’re at “A” in SOAP — assessment. This phase involves using the information and data gathered during the subjective and objective steps to arrive at a diagnosis. During assessment, nonapplicable conditions are ruled out, and a short-term and long-term outlook or prognosis is made.
Diagnosing in the DEA compliance world means assessing each aspect of your controlled substances operations.
The terms “DEA inspection” and “DEA assessment” are often used interchangeably when referring to this process, which is essentially a physical evaluation of how compliant your controlled substance operations are. Compliance assessments are routinely conducted by the DEA, state pharmacy boards and veterinary medical boards, depending on the licenses and registrations you hold and the states where you practice.
Plan
Treatment plans vary according to the diagnosis, and as is true in veterinary medicine, some are more complicated than others. On the low end of the severity scale is preventive treatment. On the higher end is surgical intervention
Treatment plans after DEA noncompliance diagnoses follow the same methodology. A veterinary practice that hasn’t experienced any serious issues but has not properly audited its controlled substances inventory might treat the problem by conducting more frequent reconciliations to ensure the counts (actual inventory) balance out and match the logbooks (expected inventory).
On the other hand, if a practice identifies theft or a significant loss of controlled substances, a surgical strike might be necessary to investigate and correct the issue.
Regardless of whether a patient is healthy or sick, wellness checks are opportunities to evaluate a patient’s overall health, assess risks and keep the patient on track through treatment plans.
SOAP alone does not prevent infection. You must use it to ensure compliance with DEA regulations. Start with a thorough cleansing to scrub off any issues and ensure nonexposure. Then wash regularly to maintain cleanliness and stay protected.
Happy sanitizing!
LEARN MORE
- Controlled Substances Act: bit.ly/45M6M4t
- Title 21 of the Code of Federal Regulations: bit.ly/4oyIdPP